NCT00137553

Brief Summary

Children participating in a study evaluating the efficacy of chloroquine and amodiaquine for the treatment of malaria will, if getting malaria during follow-up, be re-treated with sulfadoxine-pyrimethamine (SP) in accordance with the recommendations of the National Malaria Programme. To compare the actual efficacy of SP with that in 1995 - 1996 we, the investigators of the Bandim Health Project, will visit these children once a week for 5 weeks. A finger prick blood sample will be collected for a malaria test. Children with malaria during follow-up will be treated according to the guidelines of the Bandim Health Centre.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2001

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

First QC Date

August 28, 2005

Last Update Submit

March 15, 2010

Conditions

Malaria, Falciparum

Keywords

Childrenmalariasulfadoxine-pyrimethamineGuinea-Bissautreatment

Outcome Measures

Primary Outcomes (1)

  • Re-appearing parasitaemia

Interventions

Sulfadoxine-pyrimethamine (Fansidar)DRUG

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Malaria symptoms plus positive malaria film
  • \> 20 parasites per 200 leukocytes
  • Treatment failure in a study comparing chloroquine and amodiaquine
  • Informed consent

You may not qualify if:

  • Stated allergy to sulfadoxine and/or pyrimethamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Apartado 861, Bissau Region, Guinea-Bissau

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Peter Aaby, Professor

    Bandim Health Project

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2005

First Posted

August 30, 2005

Study Start

May 1, 2001

Study Completion

March 1, 2004

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

GU(1)